Testing a new approach to prevent graft-versus-host disease after stem cell transplantation
Official title: Randomized Phase 2 Study Testing Two Conditioning Regimen With a Single Prophylaxis of Graft-versus-host Disease by Cyclophosphamide and Methotrexate Post-transplant in Patients Eligible for Matched-donor Allograft Transplantation
Run by Nantes University Hospital · NCT06252870 · Data updated 2026-11-12
This study is testing a new treatment to see if a combination of two drugs can help prevent graft-versus-host disease in patients receiving stem cell transplants, allowing them to stop taking immunosuppressive drugs sooner.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 82 (estimated) |
| Sponsor | Nantes University Hospital Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, methotrexate |
| Locations | 3 sites (Angers and 2 other locations) |
| Status | Recruiting |
| Started | July 18, 2024 |
| Main results expected | October 18, 2027 |
| Study ends | July 18, 2028 |
| Registry record updated | January 26, 2026 |
| Trial ID | NCT06252870 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 to 70 with hematologic malignancies who are eligible for reduced-intensity conditioning and have a compatible HLA donor.
✕Probably not a fit
Patients with a history of allograft, those eligible for myeloablative conditioning, or with other progressive cancers may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of a combination of high-dose post-transplant cyclophosphamide and methotrexate in preventing graft-versus-host disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell transplantation with reduced-intensity conditioning. The approach seeks to allow for the early discontinuation of immunosuppressive drugs, which typically are required for several months post-transplant. Participants will receive these treatments on specific days following their transplant, and the study will compare outcomes to standard care. The goal is to improve patient outcomes and reduce the burden of long-term immunosuppression.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of GVHD and the need for prolonged immunosuppressive therapy in transplant patients.
How similar studies have gone: Previous studies have shown promising results with similar approaches in preventing GVHD, particularly in the context of haploidentical transplants, but this specific combination in reduced-intensity conditioning is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: ≥ 18 and ≤ 70 years old * Patient with hematologic malignancy * Indication for HSC allograft with attenuated conditioning * Pluripotent stem cell (PSC) engraftment * Availability of a 10/10 familial or non-familial HLA compatible donor * Consent to the protocol * ECOG \<=2 * Woman of childbearing age with negative pregnancy test and on highly effective contraception during treatment and for a period of 12 months after stopping MTX and CY * Man of childbearing age with highly effective contraception during treatment and for a period of 6 months after stopping MTX and CY and a period of 12 months after stopping MTX and CY if TBF conditioning regimen arm * Negative Hepatitis B, C, HIV serologies * Social security affiliation Exclusion Criteria: * History of allograft * Patient eligible for myeloablative conditioning (MAC) * Bone marrow transplant * Other progressive cancerous disease, or antecedent of cancer in the last five years, with the exception of a carcinoma of the skin or a carcinoma in situ of the uterine cole treated and in remission. * Progressive psychiatric condition * Pregnant or breastfeeding woman, * Woman or man of childbearing age with lack of effective contraception * Serious and uncontrolled concomitant infection * Cardiac: systolic ejection fraction \< 50% by transthoracic ultrasound or by isotopic method (isotope gamma angiography), NYHA II, III or IV heart failure, active rhythmic, valvular or ischemic heart disease or anteriority * Respiratory with EFR: DLCOc \<40% of theoretical * Renal: creatinine clearance \< 50 ml/min (assessment with MDRD method) * Urological: active urinary tract infection, history of acute urothelial toxicity due to cytotoxic chemotherapy or radiotherapy, known obstruction of urinary flow, pre-existing hemorrhagic cystitis * Hepatic: transaminases greater than 5 times normal or bilirubin greater than 2 times normal * Person protected by law (major under guardianship, curatorship or legal protection) * Vaccination against yellow fever in the last year * Known or suspected hypersensitivity to rabbit proteins as well as to the active substance and excipients of all investigational and ancillary drugs administered during the study, * Contraindication to any of the investigational or adjuvant drugs administered during the study * Patient not speaking French
Where it's running
-
CHU Angers
Angers, France Recruiting -
CHU Brest
Brest, France Recruiting -
CHU Nantes
Nantes, France Recruiting
Study contacts
- Principal investigator: Sylvain THEPOT, MD — University Hospital, Angers
- Study coordinator: Amandine LE BOURGEOIS, MD
- Email: amandine.lebourgeois@chu-nantes.fr
- Phone: 02 40 08 32 71
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Can older adults with breast cancer tolerate a dense CMF chemo schedule
This study tests whether giving a condensed CMF chemotherapy regimen is feasible for people 70 and older with breast cancer.
-
Anti-CD25 antibody to prevent acute GVHD after haploidentical stem cell transplant
This study tests whether an anti-CD25 antibody can better prevent acute graft-versus-host disease after haploidentical hematopoietic stem cell transplantation compared with the usual methotrexate-based approach.
-
Belumosudil to prevent graft-versus-host disease after a stem cell transplant
This will test whether adding the drug belumosudil to standard prevention lowers the risk of graft-versus-host disease in adults with blood cancers after a stem cell transplant.
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Adding emapalumab to standard post-transplant medicines to prevent graft‑versus‑host disease after reduced‑intensity donor stem cell transplant
This trial will test whether adding emapalumab to post‑transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil can prevent graft‑versus‑host disease in adults with AML or MDS receiving a reduced‑intensity donor stem cell transplant.
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Vedolizumab with post-transplant cyclophosphamide and short-course tacrolimus to prevent graft-versus-host disease after reduced-intensity allogeneic stem cell transplant
This trial tests whether adding vedolizumab to post-transplant cyclophosphamide and a short course of tacrolimus can prevent graft-versus-host disease in adults getting reduced-intensity allogeneic stem cell transplants for leukemias or related blood disorders.
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Reduced versus standard dose post-transplant cyclophosphamide with tacrolimus and a single low-dose ATG to prevent GVHD after alternative-donor peripheral stem cell transplant
This trial will see if a lower dose (35 mg/kg) of post-transplant cyclophosphamide plus tacrolimus and one low dose of ATG prevents graft-versus-host disease as well as the standard 50 mg/kg dose in patients receiving an allogeneic peripheral stem cell transplant from an unrelated or haploidentical donor.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.